Surgical sponge

ABSTRACT

A surgical sponge is made of a porous fabric coated on both sides with an aqueous liquid absorbing flexible foamed polymer. The sponge also contains an X-ray detectable material.

1451 Oct. 14, 1975 United States Patent 1191 Kliger I .11.. 128/2968/1972 Brooks et n a $66 3 we BmMM 7 22 6777 wwww wwww 5 63 7832 M690036678 3 33333 L S a 9 m5 mu U 78 8 a M e mm 4 mm W m L@ 1 I. l N MM 1 mamm n HN h n We n R e m U v H S h F ll 4 6 2 5 7 2 f.

Primary ExaminerRichard A. Gaudet Assistant ExaminerHenry S. LaytonAttorney, Agent, or FirmCushman Cushman 21 Appl. No.2 478,334

, Darby &

[52] U.S. 128/296' 51 1m. [58] Field of Search 128/296', 290,

ABSTRACT A surgical sponge is made of a porous fabric coated on bothsides with an aqueous liquid absorbing flexible foamed polymer. Thesponge also contains an X-ray detectable material.

References Cited UNITED STATES PATENTS -12Claims', 2 Drawing Figures2,999,041 Lappala.............................. 161/161 3,007,205161/159 SURGICAL SPONGE The present invention relates to a surgicalsponge.

Cotton gauze is generally employed as a surgical sponge. However, itmust normally be used in plural thickness, e.g., a dozen layers.Furthermore, it has the disadvantage that it produces linting. Alsothere is no means of detecting the sponge if it is accidentally left inthe patent after an operation.

According to the present invention, there is provided a surgical spongecomprising an intermediate reinforcing layer such as textile fabric orperforated plastic film having on both sides thereof an aqueous liquidabsorbing flexible, water-insoluble foamed polymer. There is alsoprovided an X-ray detectable material, e.g., barium sulfate powder in apolyvinyl chloride medium is included in the foamed laminate, preferablynext to the gauze itself. so that in the event the sponge is left in thehuman body it can be detected by X-ray techniques before (or after)closing the incision.

The preferred novel foamed pads are characterized by (i) an open cellstructure ranging from 50 to 110, preferably from 70 to 100 cells (orpores) per linear inch, (ii) a density no greater than 10 pounds percubic foot, desirably from 2 to 7 pounds per cubic foot, and preferablyfrom about 2.5 to pounds per cubic foot, (iii) a capability of beingstretched (elongated) by as much 10 percent, and even percent, withouttearing or ripping, and upon release of the stretching pressuresubstantially returning to its original dimensions, e. g., to within 23percent of its normal shape, and (iv) an ability to absorb and retain anamount of water which is at least 15, preferably 2, times the weight ofwater absorbed by cotton gauze pads of comparable dimensions; said foampads containing an X-ray detectable material therein. The noval foamedpad is flexible, soft to hand touch, non-shrinking when dry, andnontoxic to human body. A laminate according to the invention 2 X 2'having a thickness of l/16 inch to A inch, e. g, Aato inch, has theabsorption capacity of approximately 12 layers of a conventional gauze.

As intimated above, the laminated product of the present invention isstrong in all directions, tightly adhercd and nonfriable along theedges. When wet it has a soft, pliable structure which can be usedinternally as a surgical sponge which contains no contamination and isacceptable as a surgical sponge. it has a better hand than aconventional surgical sponge. The reinforcing layer can be any fabriclayer of porous. or open weave structure, e.g., it can be in the natureof gauze, cheesecloth, birdseye linen, and can be woven, e.g., gauze,loose-woven sheeting, woven scrim, loose woven cloth, knit or non-woven,e.g., spun-laced non-woven fabric or non-woven scrim fabric and can bemade of cotton, viscose, rayon, e.g., cellulose acetate rayon, nylon,wool, flax, polyester, e.g., polyethylene terephthalate,polyacrylonitrile, polypropylene, polyethylene or other material. It canalso be a perforated plastic film. Preferably, it is made of cotton. Thefoamed polymer of the sponge is preferably an open cell sponge.Preferably, it is a polyurethane sponge. The flexible polyurethane foamcan be made in conventional fashion either by a step-wise procedure(pre-polymer formation) or by the one shot technique by reacting apolyol with a polyisocyanate. The polyol can be any compound containingat least 2 hydroxyl groups, preferably two hydroxyl groups, or theequivalent, e.g., polyether polyester or polylactone'. A small amount ofa polyol of higher functionality can be included with the diol, e.g.,polyoxyethylated glycerine molecular weight 1000 or polyoxyethylatedtrimethylol propane or polyoxyethylated 1,2,6-hexanetriol. The polyolpreferably has a molecular weight of 500 to 5000 and even higher. Thus,there can be used diols such as polyethylene glycol molecular weights of500, 1000, 1500 2000, 2500, 3000, 4000, or 5000 or polypropylene glycolmolecular weights of 500, 1000, 2025, 3000, 4000 or 5000 and otherpolyether diols as well as polyesters of molecular weights 500-5000,e.g., polymerized diethylene glycol adipate molecular weight l,0003500,preferably 2000, polyethylene glycol adipate-maleate of molecular weight500-5000, ethylene glycol-propylene glycol-pimelate polyester molecularweight 500-5000, etc. Any conventional diisocyanate can be employed tomake the polyurethane, e.g., toluene diisocyanate, p,p'-diisocyanatodiphenyl methane. Typical examples of suitable polyurethanesponges of both the polyester and polyether types are set forth in BlairU.S. Pat. No. 3,806,474, Examples 1, 2 and 3. The entire disclosure ofBlair is hereby incorporated by reference. At present, polyurethanespreparedfrom either a polyether polyol or polyester polyol and toluenediisocyanate are preferred. Tailor-made properties can be achieved byfabricating the foamed pad from components containing polyether blocksor segments and as well polyester blocks or segments.

To decrease the surface tension and increase the wettability of thesponge, it can bepre-treated with a surfactant, e.g., Tween(polyoxyethylene sorbitan monooleate containing 20 ethylene oxideunits), or lgepon AC-78 (coconut oil acids ester of sodium isethionate).The surfactant (or mixture of surfactants) is used in an amount of l-lOpercent by weight of the sponge. The surfactant can be present duringformation of the sponge or can be applied to the finished sponge.

The polyurethane sponge is preferably flame laminated to the poroustextile fabric. Each sponge layer, for example, can be l/32 inch or theycan be slightly thinner or they can be thicker, e.g., A; inch or eventhicker.

In place of the polyurethane sponge there can be used any otherflexible, thermoplastic sponge,-preferably open-celled which does notdissolve or disintegrate in water, i.e., is relatively hydrolyticallystable. Thus, there can be used foams of polyethylene, polyvinyl alcoholmodified, e.g., with acetal groups such as formed groups to render itwater insoluble, polypropylene, polyvinyl chloride,hydroxyethylmethacrylate polymer, etc. The foam must be one which iscapable of absorbing water.

Flame lamination is the preferred way of adhering the foam layers to thefabric. Various non-toxic adhesives may also be used including anadhesive which contains the X-ray detectable material. The intermediatelayer, e.gl, fabric layer, acts as reinforcement for the foam.

The novel laminate desirably does not stretch more than 15 percent,preferably not more than 10 percent, in any direction and for optimumresults it should rebound to within a few percent of its normal shape,e.g., 2-3 percent.

As the X-ray detectable, i.e., X-ray opaque, material, barium sulfate ispreferred but there can be employed any other medically acceptable X-rayopaque indicators suitable for use in the human body such as carbon,e.g., finely divided, bismuth trioxide powder, verr finely dividedparticles of stainless steel or tantalum. etc. The X-ray detectablematerial is provided next to the gauze or other fabric and is preferablysupplied adhered to a thermoplastic fiber, e.g., polyvinyl chloride,nylon, polyethylene, polypropylene, polyethylene terephthalate,polyacrylonitrile, polyvinylidene chloride, polytetrafluoroethylene,etc. The particles of barium sulfate or other X-ray detectable materialcan be adhered to the thermoplastic fiber when it is in the heatedsoftened condition or simply can be mixed with the fiber formingmaterial prior to extrusion so that the X-ray opaque material ishomogeneously distributed throughout the fiber.

The X-ray detectable material containing fiber can be of the thicknessof a pencil lead for example and it can be simply placed on thereinforcing member fabric, e.g., prior to the flame lamination of thefoam or a plurality of such fibers can be dispersed at random on thefabric.

Desirably the surgical sponge is provided with a handle, e.g., a loopmade of cloth or other material, which can be sewn or otherwise securedto the laminate at a corner or along one of the edges.

The invention will be understood best in connection with the drawingswherein:

FIG. 1 is a perspective view, partially broken away in section showing asurgical sponge according to the invention; and

FIG. 2 is a fragmentary perspective view illustrating a preferred formof the invention.

Referring more specifically to the drawings wherein like numeralsindicate like parts, there is shown a surgical sponge approximately I Xl designated generically as 2 composed of an intermediate cotton gauzefabric layer 4 having flame laminated thereto polyester polyurethaneopen cell foam layers 6 and 8. The foam layers are each about l/32 inchand the overall thickness of the sponge about 1/16 inch. There areprovided on the surface of the gauze layer 4 cut polyvinyl chloridefibers 10 having dispersed throughout finely divided barium sulfatedesignated as 12. At one side of the sponge there is attached a handle16 by stitching through the foam layers.

As shown in FIG. 2 rather than a plurality of polyvinyl chloride fibersthere is provided a single barium sulfate loaded extrude polyvinylchloride fiber 14 running substantially the entire length of the spongeon one side of the fabric layer 4 and having the appearance of a pencillead. The polyvinyl chloride fiber has a diameter of about l/64 inch.

The X-ray detectable material containing film is held in place by one ofthe foamed polymer layers.

The surgical sponge of the invention will imbibe fluid during surgery.Before closing the wound a simple X-ray scan will reveal whether thesponge has accidentally been left in the body.

The sponges of the present invention are capable of being compressed ina liquid medium, e.g., aqueous liquid such as water, blood or other bodyfluids, and upon releasing the compression, absorbing the surroundingliquid therein.

The sponges of the present invention can be readily sterilized, e.g., byheat, steam, gas, radiation, etc., ei-

ther before or after packaging. They can be packaged in bags or othercontainers either in dry form or they can be packaged in bags or othercontainers containing water or other aqueous or non-aqueous liquid.

What is claimed is:

l. A surgical sponge comprising an intermediate reinforcing layer havinglaminated to both sides thereof a layer of an aqueous liquid absorbingflexible, waterinsoluble foamed polymer, said sponge having disposedtherein an X-ray opaque material whereby the presence of the sponge canbe detected by X-ray if it is accidentally left in a patient.

2. A surgical sponge according to claim 1, wherein the X-ray detectablematerial-is present in a fiber adjacent the reinforcing layer and heldin place by one of said foamed polymer layers.

3. A surgical sponge according to claim 2 having a degree of stretch ineach direction of not over 10 percent and a rebound to within 2 percentof its original shape, said sponge being strong in all directions,tightly adhered and non-friable along the edges.

4. A surgical sponge according to claim 3 wherein the X-ray detectablematerial containing fiber extends substantially along the length of thesponge, said sponge also having handle means attached thereto.

5. A surgical sponge according to claim 4 wherein the foamed polymer isan open-celled thermoplastic polyurethane foam.

6. A surgical sponge according to claim 5 wherein the reinforcing layeris a fabric layer.

7. A surgical sponge according to claim 6 wherein said fabric layer is acotton gauze fabric.

8. A surgical sponge according to claim 7 wherein the X-ray opaquematerial is a barium sulfate containing polyvinyl chloride fiber and thehandle means is a loop handle.

9. A surgical sponge according to claim 8 wherein the foamed polymerlayers include a surfactant.

10. A surgical sponge according to claim 1 wherein the X-ray opaquematerial is disposed adjacent the fabric layer and the foamed polymer isan open-celled polyurethane foam.

11. A surgical sponge comprising an intermediate reinforcing layerhaving laminated to both sides thereof a flexible polyurethane foam,said polyurethane foam beihgeharacterized by (i) an open cell structureranging' from 50 to 110 cells per linear inch, (ii) a density no greaterthan 10 cubic pounds per cubic foot, (iii) a capability of beingstretched up to ten percent without rupture and substantially returningto its original dimensions upon release of the stretching pressure, and(iv) an ability to absorb and retain an amount of water which is atleast 1.5 times the weight of water absorbed by cotton gauze pads ofcomparable dimensions; said sponge containing an X-ray detectablematerial therein.

12. A polyurethane sponge according to claim 11 wherein said open cellstructure is in the range of from to cells per linear inch, wherein saiddensity is in the range of from 2 to 7 pounds per cubic foot, andwherein said foam is characterized by an ability to absorb and retain anamount of water which is at least twice the weight of water absorbed bycotton gauze of comparable dimensions.

1. A surgical sponge comprising an intermediate reinforcing layer havinglaminated to both sides thereof a layer of an aqueous liquid absorbingflexible, water-insoluble foamed polymer, said sponge having disposedtherein an X-ray opaque material whereby the presence of the sponge canbe detected by Xray if it is accidentally left in a patient.
 2. Asurgical sponge according to claim 1, wherein the X-ray detectablematerial is present in a fiber adjacent the reinforcing layer and heldin place by one of said foamed polymer layers.
 3. A surgical spongeaccording to claim 2 having a degree of stretch in each direction of notover 10 percent and a rebound to within 2 percent of its original shape,said sponge being strong in all directions, tightly adhered andnon-friable along the edges.
 4. A surgical sponge according to claim 3wherein the X-ray detectable material containing fiber extendssubstantially along the length of the sponge, said sponge also havinghandle means attached thereto.
 5. A surgical sponge according to claim 4wherein the foamed polymer is an open-celled thermoplastic polyurethanefoam.
 6. A surgical sponge according to claim 5 wherein the reinforcinglayer is a fabric layer.
 7. A surgical sponge according to claim 6wherein said fabric layer is a cotton gauze fabric.
 8. A surgical spongeaccording to claim 7 wherein the X-ray opaque material is a bariumsulfate containing polyvinyl chloride fiber and the handle means is aloop handle.
 9. A surgical sponge according to claim 8 wherein thefoamed polymer layers include a surfactant.
 10. A surgical spongeaccording to claim 1 wherein the X-ray opaque material is disposedadjacent the fabric layer and the foamed polymer is an open-celledpolyurethane foam.
 11. A surgical sponge comprising an intermediatereinforcing layer having laminated to both sides thereof a flexiblepolyurethane foam, said polyurethane foam being characterized by (i) anopen cell structure ranging from 50 to 110 cells per linear inch, (ii) adensity no greater than 10 cubic pounds per cubic foot, (iii) acapability of being stretched up to ten percent without rupture andsubstantially returning to its original dimensions upon release of thestretching pressure, and (iv) an ability to absorb and retain an amountof water which is at least 1.5 times the weight of water absorbed bycotton gauze pads of comparable dimensions; said sponge containing anX-ray detectable material therein.
 12. A polyurethane sponge accordingto claim 11 wherein said open cell structure is in the range of from 70to 100 cells per linear inch, wherein said density is in the range offrom 2 to 7 pounds per cubic foot, and wherein said foam ischaracterized by an ability to absorb and retain an amount of waterwhich is at least twice the weight of water absorbed by cotton gauze ofcomparable dimensions.